U.S. Prefilled Syringes Market Size, Share, Analysis, By Material (Glass, and Plastic), By Closing System (Staked Needle System, Luer Cone System, and Luer Lock Form System), By Product (Complete Syringe Set and Components & Accessories), By Design (Single-chamber, Double-chamber, and Multiple-chamber), By End-user (Pharmaceutical & Biotechnology Companies, Contract Research & Manufacturing Organizations, and Others), and Country Forecast, 2024-2032

The U.S. prefilled syringes market size was worth USD 2.87 billion in 2023 and is anticipated to grow at a CAGR of 11.3% during the forecast period. 

A prefilled syringe is a unit-dose delivery device pre-loaded with the drug to be injected. These syringes are disposable and provide efficient dosage accuracy owing to the exact filling of the drug. The advantages associated with these syringes, such as convenience, ease of use, improved safety, accurate dosing, reduction in drug waste, and more, are the key factors leading to the rising adoption of these products.

Moreover, the increasing preference of healthcare providers toward biologics is further boosting the demand for these syringes as these devices spare expensive biologics by reducing drug waste and avoiding secondary contamination. The impact of the COVID-19 pandemic on the U.S. market was positive in 2020 due to the rapid use of these syringes for easy administration of the coronavirus vaccine. Furthermore, it increased demand for such syringes in the U.S. during the COVID-19 pandemic.

LATEST TRENDS

Gradual Shift Toward Biologics and Specialty Drugs to Boost Market Growth

Biologics & specialty drugs are complex molecules derived from living organisms. These drugs have specific storage and handling requirements, where prefilled syringes play a crucial role. This is leading to the rising adoption of these syringes by pharmaceutical and biopharmaceutical companies.

Also, owing to the increasing applications and more effective nature of biologics, there is a rapid shift toward biologics, gaining the attention of key players. Rising investment in these products leads to increasing approvals and is anticipated to increase the adoption of these syringes.

• For instance, in May 2023, Celltrion USA, a biopharmaceutical company, received USFDA approval for Yuflyma, a high-concentration and citrate-free formulation of Humira biosimilar for the treatment of 8 conditions, including ulcerative colitis and Crohn’s disease. The drug is the company’s 5^th biosimilar and 2^nd anti-TNF biosimilar approved in the U.S. Also, the company planned to release the product through prefilled syringes and auto-injector administration options to meet different preferences and needs.                             


• A study published in December 2021, titled “The Future of Vaccinations and Prefilled Syringes in Deep Cold Storage,” revealed that prefilled glass barrels perform normally under cold storage temperatures.

DRIVING FACTORS

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Rising R&D Investment and Introduction of New Products to Drive Market Growth

The increasing focus of key market players to develop innovative products leads to market expansion with a wider range of products to cater to a vast patient pool. To incorporate innovation on existing and new products, key companies invest a significant amount in R&D and product approvals leading to new products that further drive market growth.

• For instance, in September 2022, BD announced the launch of BD Effivax, a glass prefillable syringe with specifications for cosmetics, processability, integrity, and contamination. The product was developed in collaboration with pharmaceutical companies to support the complex needs of vaccine manufacturing. Also, BD invested around USD 1.2 billion to expand and upgrade manufacturing capacity and technology for prefillable syringes.

Moreover, the increasing patient pool suffering from chronic conditions, including rheumatoid arthritis, multiple sclerosis, and hormonal replacement therapy (HRT), among others, are leading to higher demand for prefilled syringes for drug delivery. Therefore, the growing prevalence of chronic diseases and disorders further boosts the demand for these syringes and is anticipated to contribute to U.S. prefilled syringes market growth during the forecast period.

RESTRAINING FACTORS

Rising Number of Product Recalls to Disrupt the Brand Value and Limit Market Growth  

The complex manufacturing and drug-filling process in the syringes creates multiple chances of infections. A prefilled syringe has 4 components, and any contamination in any one component may attract the attention of the FDA in the country. Recalls are associated with substantial financial losses for manufacturers, impact financial position, and limit these companies' investment in R&D, further limiting market growth.

• For instance, in August 2021, Cardinal Health announced the voluntary recall of 267,217,860 monoject saline flush prefilled syringes in the U.S., under class I recall. The company recalled 3 models of these syringes due to the risk of air entry into the syringe during plunger pulling.

SEGMENTATION

By Material Analysis

Based on material, the market is bifurcated into glass and plastic.                                                                                    

In 2022, the glass segment captured the largest market share due to its less impact on the environment and high acceptance of glass compared to plastic leading to more penetration of glass as a material. However, owing to the high chances of material breakage and leaching into the drug, there is a rapid shift toward prefilled plastic syringes which is anticipated to register a notable growth rate during the forecast period.

• For instance, in September 2021, a study conducted by BD revealed that deep cold storage temperatures can induce changes in container dimensions; however, glass as a material performs well in such low temperatures. The company conducted a study on glass material to analyze the impact of temperatures such as -20°C and -40°C on glass prefillable syringes and found no impact on the drug or material property in the given temperature.

By Closing System Analysis

The closing system segment is categorized into luer lock form system, luer cone system, and staked needle system.

The staked needle system segment held a larger share in 2022 due to the reduced risk of medical error and improved & streamlined workflow. However, the luer lock form system is anticipated to register faster growth owing to its strong leak-proof connection between the syringe and needle, reducing the chances of accidental detachment. Also, these systems are more compatible with other accessories, such as filters, extension lines, or infusion sets, leading to more product adoption. Thus the advantages associated with the luer lock form system and increasing product launches will likely contribute to market growth during the forecast period.

• For instance, in April 2023, Hikma Pharmaceuticals PLC announced the U.S. launch of Regadenoson injection in prefilled syringe form. The prefilled plastic syringe contains the unit dose of 0.4 mg/5 mL with a luer-lock fitting.

By Product Analysis

The product segment is categorized into components & accessories and complete syringe sets.                                                                     

The complete syringe set segment accounted for a larger U.S. prefilled syringes market share in 2022 due to the rising adoption of self-injecting parenteral devices among patients leading to increased demand for a complete syringe set. Also, the increasing prevalence of diabetes is one of the key factors encouraging the use of a complete syringe set while performing the self-administration of insulin.

• For instance, according to a report published by the Centers for Disease Control and Prevention (CDC), in 2021, 37.3 million people had diabetes, constituting about 11.3% of the U.S. population. Also, the disease prevalence is rising at a rate of 14.7%.

By Design Analysis

The design segment is categorized into multiple-chamber, double-chamber, and single-chamber.

In 2022, the single-chamber segment held the largest share. The segment is anticipated to grow significantly owing to cost-effectiveness, compatibility, and its long storage and shelf life compared to double or multiple chambers. However, dual chamber prefilled syringes are emerging as a better-suited solution owing to high quality and convenient drug delivery, gaining customers' attention, and is expected to grow during the forecast period.

By End User Analysis

The end user segment is categorized into contract research & manufacturing organizations, pharmaceutical & biotechnology companies, and others.

Due to the rapid expansion of the pharmaceutical & biopharmaceutical companies, the segment accounted for the largest market share among end users. Also, an increasing orientation of healthcare professionals toward biologics and biosimilars is anticipated to contribute to the segment’s growth in the coming years.

KEY INDUSTRY PLAYERS

Key players such as Becton Dickinson and Company (B.D.), Gerresheimer AG, and SCHOTT AG accounted for significant market share in 2022. The increasing R&D expenditure, rising number of product approvals, and strong distribution network of the key market players in the U.S. are the key factors driving the market growth during the forecast period.

• For instance, in May 2023, BD announced the availability expansion for its prefilled saline flush syringe, PosiFlush SafeScrub, to simplify nursing workflow and reinforce infection prevention guidelines.

Moreover, other emerging players, such as AptarGroup, Inc. and Nipro PharmaPackaging International, continuously create product awareness with their active participation in exhibitions and other key strategies.

• For instance, in October 2021, AptarGroup, Inc. sponsored the “PDA Universe of Prefilled Syringes & Injection Devices Conference” and showcased its components for Prefilled Syringes.

Thus, expansion in product offerings along with increasing strategic alliances are expected to enable companies further to strengthen their market presence.

LIST OF KEY COMPANIES PROFILED:

• B.D. (U.S.)


• Gerresheimer AG (Germany)


• SCHOTT AG (Germany)


• West Pharmaceutical Services Inc. (U.S.)


• Helvoet Rubber & Plastic Technologies BV (Netherlands)


• Nipro PharmaPackaging International (Belgium)


• AptarGroup, Inc. (U.S.)


• Terumo Corporation (Japan)

KEY INDUSTRY DEVELOPMENTS: 

• April 2023: CSL received the U.S. FDA approval for Hizentra in a 50 ml prefilled syringe. Hizentra is an immune globulin subcutaneous liquid for chronic inflammatory demyelinating polyneuropathy and primary immunodeficiency.


• March 2023: Techdow USA, a generic injectable company, received the U.S. FDA approval for generic Lovenox, a preservative-free Enoxaparin Sodium injection in a prefilled syringe for patients with deep venous thrombosis.


• February 2023: AstraZeneca received the U.S. FDA approval for Tezspire, a respiratory biologic drug for self-administration through a prefilled syringe. The drug is used for the treatment of severe asthma in 12 years and older patients.

REPORT COVERAGE

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The U.S. prefilled syringes market report provides a detailed analysis of the market. It focuses on key aspects such as regulatory scenarios, market trends, and technological advancements. Additionally, it includes new product launches, key industry developments such as mergers, partnerships, & acquisitions, and the impact of COVID-19 on the market. Besides this, the report also highlights key industry dynamics.

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